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In ischemic stroke, the recanalization rate after intravenous thrombolysis has been estimated to be less than 50% in patients with proximal intracranial artery occlusion; this rate is greater than 80% after endovascular thrombectomy. Thromboelastometry is a method of analysis of coagulation and fibrinolysis in whole blood. The main objective of this study is to evaluate whether the parameters obtained by thromboelastometry are predictive of revascularization at arteriography during mechanical thrombectomy, after treatment with rt-PA thrombolysis.
This is a single-center prospective observational study at the University Hospital of Caen. Any patient presenting a neurological deficit of sudden onset, compatible with a ischemic stroke diagnosed on brain imaging and eligible for thrombolysis by rtPA and/or a endovascular thrombectomy procedure will be included. Clot formation kinetics will be assessed by thromboelastometry (ROTEM® and/or QUANTRA®) to determine the predictive parameters of revascularization. The parameters of clot formation and lysis as well as revascularization according to thrombo-inflammation processes will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sucess of revascularization | group of patients for whom after thrombolysis neurological improvement will be observed and recanalization on imaging will be seen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thromboelastometry test | Other | This study does not modify the usual care of the patient. Only 5 citrated tubes (maximum 15 mL of blood) are collected in addition to the initial emergency department sample (routine care). The patient's care follows the classic thrombolysis alert pathway. There is no additional complementary examination or additional neurological evaluation. Clot formation kinetics will be evaluated by thromboelastometry to determine the predictive parameters of revascularization. Clot formation and lysis parameters as well as revascularization according to thrombo-inflammation processes will be studied. |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of the success of the revascularization procedure by thromboelastometry | All the parameters of clot formation and lysis will be studied, in particular the area under the curve (AUC) | One hour after the blood test |
| Does clot firmness could predict the success of the revascularization | clot firmness (MCF in millimeter, mm) | One hour after the blood test |
| Prediction of the success of the revascularization procedure by thromboelastometry | clot lysis time (seconde). | One hour after the blood test |
| Measure | Description | Time Frame |
|---|---|---|
| Thomboelastometry and prediction of thrombolysis + thrombectomy efficacy | effectiveness of thrombectomy will be assessed per-arteriogram by the TICI score (Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients >18 years with a diagnosis of ischemic stroke compatible and eligible for intravenous thrombolysis (IVT) with rt-PA and/or endovascular thrombectomy (EVT).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clémence h Tomadessos | Contact | +33231065386 | +33231065386 | tomadesso-c@chu-caen.fr |
| Richard Macrez | Contact | +33231065386 | +33231065386 | macrez-r@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Richard Macrez, Doctor | University hospital of Caen and faculty of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Caen, emergency department | Caen | 14000 | France |
Sample and clinical could be share with private researcher (STAGO)
At the end of the inclusion period
The clinical and biological databases will be recorded by investigators and laboratory biologists respectively from the existing hospital information system. Anonymized data will be transferred via a secure server and encrypted messaging
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| during thrombectomy procedure |
| Thomboelastometry and prediction of thrombectomy efficacy | number of passes required for successful recanalization thrombolysis | immediatly after thrombectomy procedure |
| Thomboelastometry and prediction of thrombectomy efficacy | puncture to recanalization (minute) | through study completion, an average of 3 years |
| Thomboelastometry and prediction of success of recanalization by thrombectomy alone | Effectiveness of thrombectomy will be assessed by the TICI score ((Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion) | just at the end of thrombectomy procedure |
| Prediction of success of thrombolysis | presence or absence of a clot on MRI or angioscan | "Day 1", "Day 3" after thrombolysis |
| Thomboelastometry and prediction of neurological outcome | The use of the NIHSS score will allow the neurological evaluation of the patient (at admission and 24h/72h after the recanalization attempt). Neurological outcome, as assessed by the NIHSS score, is considered favorable if the NIHSS score at 24h/72h post-recanalization is equal to 0 or 1 or if there is an improvement in the NIHSS score of at least four points between the admission score and the score at 24h/72h post-recanalization. | "D0", "Day 1", "Day 3" after revascularization |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |